Streptococcus A Self-Test Antigen Rapid Test - IVDR
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A rapid, easy-to-use self-test for the detection of Streptococcus A antigen in throat swab specimens, IVDR compliant.
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Why Choose Our Strep A Self-Test?
Our Strep A Self-Test allows individuals to quickly and conveniently test for Streptococcus pyogenes at home. It provides rapid results, enabling early detection and appropriate medical consultation. IVDR compliance ensures safety and performance.
Inside NomoFlow™: The Source of This Test's Superior Performance
The Streptococcus A Self-Test demonstrates high clinical performance compared to laboratory methods.
Performance Characteristics
| Analyte | Sensitivity (PPA) | Specificity (NPA) | Overall Agreement |
|---|---|---|---|
| Streptococcus pyogenes (Group A Strep) Antigen | 93.5% (95% CI: 87.2-96.9%) | 98.0% (95% CI: 95.5-99.2%) | 96.5% |
Relevant studies and publications will be available here soon.
| Time to Result | 5 minutes |
|---|---|
| Sample Type | Throat Swab |
| Kit Size | 1 Test/Kit |
| Storage Conditions | 2-30u00b0C |
| Shelf Life | 24 months |
| Included Materials | Test Cassette, Swab, Extraction Reagent, Instructions for Use |
| Required Materials (Not Included) | Timer |
| Certifications | CE, IVDR, ISO 13485 |
Collect Sample
Collect throat swab specimen following instructions.
Extract Sample
Mix swab with extraction reagent.
Apply to Cassette
Apply extracted sample to the test cassette.
Read Results
Read results after 5 minutes.
Product Information
- Catalog Number: BAC-SASAG
- Product Name: Streptococcus A Self-Test Antigen Rapid Test - IVDR
Download product documents for more information.
Frequently Asked Questions
Direct answers regarding clinical performance, workflow, and logistics.
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Integrate into a Complete Respiratory Workflow
This test is a key component of a broader strategy for managing respiratory outbreaks, optimizing resource allocation, and improving patient outcomes. See how it fits into a complete workflow solution.
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